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FDA FVIII vCJD Risk Assessment: A global perspective

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It is important to avoid the complacency which characterized ... Journal of Thrombosis and Haemostasis 4 (3), 510-516. doi: 10.1111/j.1538-7836.2006.01808.x ... – PowerPoint PPT presentation

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Title: FDA FVIII vCJD Risk Assessment: A global perspective


1
FDA FVIII vCJD Risk AssessmentA global
perspective
Mark W. SkinnerWFH President
  • 15 December 2006 FDA TSEAC Meeting
    Washington, DC

2
WFH Guidance on Assessing Product Risk
  • It is important to avoid the complacency which
    characterized previous blood borne epidemics in
    people with hemophilia, while retaining a sense
    of proportion to this particular issue, and
    maintain a constant watch on the balance between
    safety and supply
  • Structured risk-management processes require a
    strategy for continuous learning and communication

A. Farrugia vCJD and Hemophilia Further
Guidance on Assessing the Risk of Plasma-Derived
Products for Treating Hemophilia WFH 2004
3
Risk Communication Core Values
  • Follow a precautionary approach when scientific
    knowledge is incomplete
  • Patients have a right to be consulted and
    informed
  • Timely communication with openness and
    transparency
  • Clear and comprehensible explanations essential
  • Appropriate to acknowledge areas of uncertainty
  • Avoid unintended health consequences
  • e.g.) patient stigmatization, denial of access to
    care

4
Potential Global Implications
  • 75 of the patients in the world receive little
    or no care
  • Outside of the highly developed nations,
    treatment products are predominantly
    plasma-derived

Source WFH Global Survey 2005 Random sample of
45 countries
5
Placing Risk in Context
  • Mortality and Causes of Death in PWH
  • Before the introduction of clotting factor
    preparations, the mean life expectancy of
    patients with hemophilia was lt30 years, and
    patients mostly died of intracranial or other
    hemorrhages
  • In patients with severe hemophilia not infected
    with viruses, mortality is still 40 higher when
    compared with the general population
  • 27 (13/49) of the deaths in the cohort of
    patients not infected with HCV or HIV were
    because of hemorrhage

PLUG, I., et. al., Mortality and causes of death
in patients with hemophilia, 19922001 a
prospective cohort study. Journal of Thrombosis
and Haemostasis 4 (3), 510-516. doi
10.1111/j.1538-7836.2006.01808.x
6
Quantifying the Risk in Global Context
  • FDA risk assessment builds on global knowledge
    and understanding
  • U.K. 2004 U.K. plasma-derived concentrates 1
    additional risk beyond general population risk of
    14,225 to 1.81,000,000
  • FDA 2006 U.S. plasma-derived concentrates
    between 1105,000 19,400,000
  • FDA assessment is significantly lower than the
    U.K. assessment and thus provides further
    reassurance for patients clinicians

7
Selection of Treatment Product
  • The FDA assessment adds to our understanding and
    provides reassurance for both clinicians and
    patients when making treatment product selection
    decisions
  • The WFH continues to view both recombinant and
    plasma-derived products as important treatment
    options for the global bleeding disorders
    community
  • Potential remains for adverse events including
    inhibitor development or unknown pathogen risk,
    thus continuous learning and communication are
    required
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